1911-1943: Continued non-existence of legal provisions directing federal agencies to establish and enforce biological product definitions and standards.
1911-1943: Continued non-existence of legal provisions directing federal agencies to establish and enforce biological product definitions and standards.
Part 4 of series on US federal quarantine and biological product law, 1798 to 1972
Orientation for new readers; American Domestic Bioterrorism Program; Tools for dismantling kill box anti-law
1798-1972 US federal quarantine and biological product law series:
1911-1943: Continued non-existence of legal provisions directing federal agencies to establish and enforce biological product definitions and standards.
By Lydia Hazel1 and Katherine Watt
Part 3 Summary:
The 1902 Virus-Toxin law, also known as the Biologics Control Act, authorized a three-member board (Supervising Surgeon-General of the Public Health and Marine-Hospital Service; Surgeon-General of the Army; and Surgeon-General of the Navy) to promulgate rules addressing licensure of manufacturing establishments only, not products.
Congress was silent as to the identity, purity, potency, safety and therapeutic efficacy of factory-propagated, undefined products including viruses, toxins, antitoxins and serums. Congress was silent as to specimen collection and analysis, and did not designate a laboratory to conduct testing of samples. Congress was silent as to product recall, seizure and destruction procedures.
Congress required labels to contain the proper name of the "article" and the address of the establishment, but did not require labels to contain information about ingredients, volumes, concentrations, or other measurable physical or chemical properties.
Congress did not identify district attorneys, or any other law enforcement officers, or impose a duty to prosecute violators.
Products propagated in virus and toxin establishments were not covered by the provisions of 1906 Pure Food and Drug Act, which defined drugs as "all medicines and preparations recognized in the United States Pharmacopeia-National Formulary [USP-NF] for internal or external use, and any substance or mixture of substances intended to be used for the cure, mitigation, or prevention of disease of either man or other animals;" required submission of "specimens" to the Department of Agriculture Bureau of Chemistry for analysis; and imposed, upon district attorneys, a duty to criminally prosecute violators.
Part 4 of this series provides summaries of important Congressional, Presidential and Cabinet secretary acts and Supreme Court decisions that took place between 1911 and 1943.
After each summary, we've provided a few key points, and plan to publish further analysis after the five-part series has been published in full.
Readers are encouraged to think about how these earlier forms of scientific, medical and regulatory deception — federally authorized and funded toxin research, federally-licensed toxin manufacturing, and interstate and international trafficking in toxins camouflaged as medicinal products — have been rendered more visible, in their more developed forms, through the fabrication of the Covid-19 pandemic and public health and vaccination programs ostensibly mounted in response to it.
Several other laws enacted during this period are not covered here, but are related to financial, medical, scientific, and legal government-authorized, government-funded criminal enterprises as constructed by Congress, US Presidents, Cabinet secretaries and federal judges. The related statutes, court decisions and executive orders include the 1913 Federal Reserve Act; 1917 Espionage Act; 1917 Trading with the Enemy Act; 1921 Joint Resolution Declaring that certain Acts of Congress, joint resolutions, and proclamations shall be construed as if the war had ended and the present or existing emergency expired," excluding Trading with the Enemy Act and others; 1925 Act to Amend the Judicial Code; 1933 Emergency Banking Act; 1933 House Joint Resolution 192; 1938 Erie v. Tompkins Supreme Court decision.
How US government sources describe the effects of the 1902 Virus-Toxin law
Immunize.org Vaccine History Timeline:
"The standards imposed by the 1902 [Virus-Toxin] Act resulted in bankruptcy for one-third of the companies manufacturing antitoxins and vaccines while benefiting the manufacturers already in compliance. In total, 10 firms held licenses with the Laboratory of Hygiene [in operation since 1887] following the 1902 Act."
"In 1902 two acts contributed significantly to the emergence of the Hygienic Laboratory as a center for research within the federal government...the act launched a formal program of research by designating the pathological and bacteriological work as the Division of Pathology and Bacteriology and by creating three new components that represented the most fruitful areas for research at that time: the Divisions of Chemistry, Pharmacology, and Zoology. The importance of these new programs was underscored by the provision that the PH-MHS could hire scientist researchers with Ph.D.'s to head them. Up until this time, the professional staff had been limited to physicians..."
Note:
The 1902 Virus-Toxin law did not include the words pathology or bacteriology. By 1910, Milton Rosenau, the director of the Hygienic Laboratory, referred in a JAMA paper to the 'division of pathology and bacteriology' and made two contradictory claims: that the division's employees examined samples of antitoxins and vaccine virus "for potency and purity" and that “Vaccine virus is the specific principle in the material obtained from the skin eruption of calves [1] having a disease known as vaccinia.…This material scraped from the skin eruption is called vaccine 'pulp.' The fluid which exudes after the pulp is taken is called vaccine 'lymph.' Both the pulp and the lymph are mixtures containing epithelial cells, serum, blood, leucocytes, products of inflammation, debris, bacteria, etc., in varying proportions…The specific principle of vaccinia is unknown."
1911 to 1943 - Congress, SCOTUS, Presidents and Cabinet secretaries
From 1911 to 1943, Congress continued funding Public Health Service programs, including research at the Hygienic Lab; treatment of patients at marine hospitals; operation of quarantine stations and medical inspection of aliens arriving on foreign ships at US ports; and federal payments to state and local health boards for "prevention of epidemics." Compilation of Congressional funding acts, 1904-1943.
Funding acts in the timeline below are denoted with double-asterisk** symbols.
**In 1911, Congress funded maintenance of marine hospitals, adding: "Provided, that there may be admitted into said hospitals for study, persons with infectious or other diseases affecting the public health, and not to exceed ten cases in any one hospital at one time."
1911 - Supreme Court ruled, in US v. Johnson, on applicability of 1906 Pure Food and Drug Act misbranding provisions to claims about therapeutic or curative value of drugs. - US v. Johnson, 221 US 488
Between 1907, when the 1906 Pure Food and Drug Act entered into force, and 1910, officers of the US Department of Agriculture and district attorneys applied the law to "nearly 30 cases" in which drug manufacturers falsely claimed their products had curative properties. In each case, "either no defense [was] made, or pleas of guilty had been entered."
One of the manufacturers challenged his prosecution for interstate delivery of packages of medicine "bearing labels that stated or implied that the contents were effective in curing cancer, the defendant well knowing that such representations were false."
The District Court quashed the indictment, prompting the US government to appeal to the Supreme Court.
Johnson didn't dispute that the label statements alleging curative properties were false. He argued that Section 8 of the 1906 Pure Food and Drugs Act "confined" the term 'misbranded' to "representations concerning the identity of the drug, its physical constituents, or chemical ingredients" and did not cover to claims for curative properties.
After a lot of textual analysis, by a 6-3 decision, the Supreme Court held that Johnson and the lower court were correct.
Held:
"The term "misbranded" and the phrase defining what amounts to misbranding in § 8 of the Food and Drugs Act ... are aimed at false statements as to identity of the article, possibly including strength, quality and purity, dealt with in § 7 of the act, and not at statements as to curative effect; and so held that a statement on the labels of bottles of medicine that the contents are effective as a cure for cancer, even if misleading, is not covered by the statute."
The majority opinion and the dissent are worth reading for insights into how federal courts construed "matters of scientific opinion," as addressed in medical treatment contexts and "all health and quarantine laws," and "the constitutional power of Congress to prohibit use of the instruments of interstate commerce to the injury of the public."
Key point:
Viruses, toxins, serums, vaccines and related biological products manufactured or propagated at licensed establishments under the 1902 Virus-Toxin law were not subject to any of the provisions of the 1906 Pure Food and Drug Act. Virus and toxin manufacturers were not required to provide, on package labels, any information about ingredient identity, volumes, weights, concentrations, or effects. Congress was silent on the adulteration and misbranding of virus and toxin products.
1912 - An Act to change the name of the PHMHS to the PHS - PL 62-265
In August 1912, Congress changed the name of the Public Health and Marine-Hospital Service to the Public Health Service; transferred existing PHMHS laws and regulations to the PHS; authorized PHS, including the Hygienic Laboratory, "to study and investigate the diseases of man and conditions influencing the propagation and spread thereof, including sanitation and sewage and the pollution either directly or indirectly of the navigable streams and lakes of the United States;" and authorized PHS to "from time to time issue information in the form of publications for the use of the public."
At Section 2, Congress increased the pay scale for the Surgeon General, Assistant Surgeon General and other officers.
Key points:
Congress did not define the term public health.
Congress did not expand on the 1902 Virus-Toxin law; the terms viruses, toxins, serums and analogous products remained undefined. Congress did not transfer responsibility for drafting of biological product regulations from the control of the three-member Surgeon-Generals board Congress had designated in 1902.
Congress did not authorize the PHS Surgeon General or Hygienic Laboratory Director to set or enforce regulations governing virus and toxin product identity, concentration, weights, volumes or other physically or chemically measurable properties, and Congress did not define adulteration or misbranding for virus and toxin products, or authorize criminal prosecution for adulterated or misbranded virus and toxin products.
1912 - An Act to amend section eight of the 1906 Pure Food and Drug Act - PL 62-301
In response to the 1911 US v. Johnson Supreme Court ruling, Congress amended the 1906 Pure Food and Drug Act to further define the term misbranding.
Congress added a third paragraph to Section 8 of the 1906 law, deeming an article misbranded "If its package or label shall bear or contain any statement, design or device regarding the curative or therapeutic effect of such article or any of the ingredients or substances contained therein, which is false or fraudulent."
Key point:
The provisions of the 1906 Pure Food and Drug Act, including the 1912 amendment deeming false or fraudulent claims as to curative or therapeutic effect to be misbranding, were not applicable to viruses, toxins and other biological products propagated at establishments licensed under the 1902 Virus-Toxin law.
The 1902 Virus-Toxin law did not address, define or set up procedures to identify and prosecute adulteration or misbranding of biological products.
As of 2024, Congress has still not addressed, defined or set up procedures to identify and prosecute adulteration or misbranding of biological products, nor have any of the federal agencies to which Congress has delegated regulatory authority.
** In 1913, Congress funded the Public Health Service; promoted the director of the Hygienic Laboratory to receive the pay and allowance of a PHS senior surgeon; authorized PHS to conduct "field investigations of public-health matters...diseases of man and conditions influencing the propagation and spread thereof, including sanitation and sewage, and the pollution of navigable streams and lakes;" and funded construction of new buildings at the Hygienic Lab for "research work, disinfection, experiments and housing animals."
**In 1913, Congress added to the program providing federal payments to state and local health boards, another program for "cooperating with state and local authorities," called "Interstate quarantine service."
1913 - An Act to amend section eight of the 1906 Pure Food and Drug Act - PL 62-419
In 1913, Congress amended the 1906 Pure Food and Drug Act again.
The original act deemed an article misbranded if (among other definitions) "...Third. If in package form, and the contents are stated in terms of weight or measure, they are not plainly and correctly stated on the outside of the package."
In 1913, Congress added a conditional clause: "Provided, however, That reasonable variations shall be permitted, and tolerances and also exemptions as to small packages shall be established by rules and regulations made in accordance with Section 3 of this act."
Key points:
The provisions of the 1906 Pure Food and Drug Act, including the 1913 amendment authorizing "reasonable variations" in weight and measure of packaged drugs, were not applicable to viruses, toxins and other biological products propagated at establishments licensed under the 1902 Virus-Toxin law.
The 1902 Virus-Toxin law did not address, define or set up procedures to identify and prosecute adulteration or misbranding of biological products.
As of 2024, Congress has still not addressed, defined or set up procedures to identify and prosecute adulteration or misbranding of biological products, nor have any of the federal agencies to which Congress has delegated regulatory authority.
1913 Virus-Serum-Toxin Act, licensing biological products to be used on domestic animals - PL 62-430, 37 Stat. 832
In 1913, as part of an act funding the US Department of Agriculture, Congress set up a licensing scheme prohibiting preparing, selling, bartering or exchanging any "worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous product intended for use in the treatment of domestic animals..."
This law was later codified at 21 USC 151-159, and USDA promulgated regulations at 9 CFR Chapter 1, Subchapter E, Parts 101 to 124.
Because it was part of a funding act, the livestock product law was not divided into sections; it was simply a lengthy paragraph.
Condensed:
...For...expenses for scientific investigations in diseases of animals...and...for investigations of tuberculin, serums, antitoxins, and analogous products, $78,680...
...After July 1, 1913, it shall be unlawful for any person, firm, or corporation to prepare, sell, barter, or exchange in the District of Columbia...Territories...or any place under the jurisdiction of the US...or ship or deliver for shipment from one State or Territory or DC to any other State...Territory or DC, any worthless, contaminated, dangerous or harmful virus, serum, toxin, or analogous product intended for use in the treatment of domestic animals...
No person, firm or corporation shall prepare, barter, exchange or ship any virus, serum, toxin or analogous product manufactured within the US...unless and until the...product shall have been prepared under and in compliance with regulations prescribed by the Secretary of Agriculture, at an establishment holding an unsuspended and unrevoked license issued by the Secretary of Agriculture...
Importation...without a permit...and importation of any worthless, contaminated, dangerous or harmful virus, serum, toxin or analogous product...are hereby prohibited...
Secretary of Agriculture is...authorized to cause the Bureau of Animal Industry to examine and inspect all...products...which are being imported or offered for importation...to determine whether such viruses, serums, toxins, and analogous products are worthless, contaminated, dangerous, or harmful...and if it shall appear that any such [product] is worthless, contaminated, dangerous, or harmful...the same shall be denied entry and shall be destroyed or returned at the expense of the owner or importer...
Secretary of Agriculture is...authorized to make and promulgate...rules and regulations...to prevent the preparation, sale, barter, exchange, or shipment...of any worthless, contaminated, dangerous or harmful virus, serum, toxin, or analogous product for use in the treatment of domestic animals, and to issue, suspend, and revoke licenses for the maintenance of establishments for the preparation of viruses, serums, toxins and analogous products...
Secretary of Agriculture is authorized to issue permits for...importation...of products...which are not worthless, contaminated, dangerous or harmful...
Licenses issued...to establishments where such...products are prepared...shall be issued on condition that the licensee shall permit the inspection of such establishments and of such products and their preparation...
The Secretary of Agriculture may suspend or revoke any permit or license issued under...this Act, after opportunity for hearing has been granted to the licensee or importer, when the Secretary...is satisfied...that such license or permit is being used to facilitate or effect the preparation, sale, barter, exchange, or shipment...or importation...of any worthless, contaminated, dangerous or harmful virus, serum, toxin, or analogous product...
Any officer...of the Department of Agriculture duly authorized...may, at any hour during the daytime or nighttime, enter and inspect any establishment...
Any person, firm, or corporation who shall violate any of the provisions...shall be deemed guilty of a misdemeanor, and...upon conviction...punished by a fine of [up to] $1,000 or by imprisonment [up to] one year, or by both...
There is hereby appropriated...for the purposes and objects of this Act...$25,000...
For construction of buildings at bureau experiment station at Bethesda, Maryland, and bureau experiment farm at Beltsville, Maryland, $16,500...
The Secretary of Agriculture is authorized to prepare and sell at cost such pathological and zoological specimens as he may deem of scientific or educational value to scientists or others engaged in the work of hygiene and sanitation...
Key points:
Congress did not define virus, toxin, antitoxin or analogous product in measurable, verifiable physical or chemical terms, and did not cite to or delegate authority to the US Pharmacopeia or National Formulary compendia to define these products in measurable, verifiable physical or chemical terms.
Congress did not define the terms worthless, contaminated, dangerous, or harmful.
Congress did not address product labeling or require any information to appear on product labels, did not address or define safety or efficacy, and did not prohibit adulteration or misbranding.
Congress did not require manufacturers to submit product specimens to the Bureau of Animal Industry, and did not require the Bureau of Animal Industry to collect or test specimens, or develop assays (tests) to identify product contents or determine weights, volumes, concentrations, purity, potency or other properties of ingredients.
Similarities between 1902 Virus-Toxin law (human) and 1913 Virus-Serum-Toxin Act (domestic animal):
Product definition and identity. Both laws were silent on defining products by identity, ingredients and physical or chemical attributes.
Safety and efficacy. Both laws were silent on defining safety and effectiveness.
Establishment inspections. Both laws were silent on what intervals, if any, establishments were to be inspected, describing inspections with the optional "may," not the mandatory "shall."
Specimen collection and analysis. Both laws were silent on the submission, collection and analysis of product specimens.
Duty to prosecute. Both laws were silent on delegation of duty to report infractions (noncompliance with undefined standards) to any prosecutorial body, and silent on duty to prosecute.
Sale, barter or governmental purchase, distribution and use. Both laws were limited to products intended for sale and barter, and silent on products intended for governmental purchase, distribution and use.
Differences between 1902 Virus-Toxin law (biologic products for human use) and 1913 Virus-Serum-Toxin Act (biologic products for domestic animal use):
Terms denoting noncompliance. For human products (1902), the basis of infraction was not defined in measurable physical or chemical terms; instead, the law prohibited products that had been produced in an unlicensed establishment, or bearing a label not containing the proper name of the product, the address and license number of the manufacturer and a "date beyond which the contents cannot be expected beyond reasonable doubt to yield their specific results," with no definition of the term specific results, or procedures for assessment. For animal products (1913), the basis of infraction was also not defined in measurable physical or chemical terms; instead, the law prohibited (without definition) "worthless, contaminated, dangerous or harmful" products.
Import permits; licenses. Foreign manufacturers of human products (1902) were to be granted establishment licenses. Foreign manufacturers of animal products (1913) were to be granted permits.
Inspectors. The 1902 law designated unidentified agents of the Treasury Secretary as establishment inspectors. The 1913 law designated agents of the Department of Agriculture Bureau of Animal Industry.
Inspection of imports. Under the 1902 human products law, imported products "may" be inspected at their foreign place of manufacture. Under the 1913 animal products law, all imported animal products were to be inspected at point of entry, not their place of manufacture.
Hearings. Manufacturers and importers of animal products were entitled to hearings regarding pending permit or license suspension/revocation. Manufacturers of human products were not. However, if Treasury failed to notify a virus or toxin manufacturer that his establishment license had been revoked or suspended, he could continue producing and distributing viruses and toxins.
Similarities between the 1906 Pure Food and Drug Act (non-biologic drug products for human use) and 1913 Virus-Serum-Toxin Act (biologic products for animal use):
Inspection intervals. The 1906 human drug law and the 1913 animal virus and toxin law were both silent on setting specific intervals for inspection of manufacturing establishments or specimens.
Bureau tasked with inspection. The 1906 human non-biological drug law named the USDA Bureau of Chemistry as the authorized inspecting laboratory. The 1913 animal products law named the USDA Bureau of Animal Industry as the authorized inspecting laboratory for animal viruses, serums and toxins.
Products not intended for sale or barter. The 1906 human drug law and the 1913 animal virus and toxin law were both silent as to regulation of products not intended for sale or barter, and not intended to cross state/territory/DC borders for interstate trafficking or import and export across national borders.
Hearings. The 1906 human drug law and 1913 animal virus and toxin law both provided procedures for hearings for alleged violators to challenge allegations of noncompliance.
Differences between the 1906 Pure Food and Drug Act (non-biologic drug products for human use) and 1913 Virus-Serum-Toxin Act (biologic products for animal use):
Product definition and identity. Under the 1906 human drug law, drugs were defined by reference to physical and chemical composition and analytical testing procedures published in the US Pharmacopeia-National Formulary compendia. Under the 1913 animal viruses and toxins law, products were not defined by physical or chemical standards or analytical tests.
Basis for prohibition. For human drugs (1906), the bases for prohibition were that a product was found to be adulterated and/or misbranded, and both terms were defined. For animal viruses and toxins (1913), the bases for prohibition were undefined qualities of the product, i.e., worthless or harmful.
Product regulation; facility regulation. Under the 1906 human drug law, Bureau of Chemistry inspectors were authorized to collect and test specimens of individual products to assess adulteration or misbranding. Under the 1913 animal virus and toxin products law, manufacturing facilities could be inspected by Bureau of Animal Industry officers, but individual products were not subject to specimen collection or analysis.
State, Territory and DC authority. Under the 1906 human drug law, the health officers for States, Territories and the District of Columbia were authorized to submit specimens collected within their jurisdictions, for analysis by the USDA Bureau of Chemistry. The 1913 animal virus and toxin law was silent on the authority of State, Territory and D.C. officers to collect and submit samples for analysis.
Rulemaking authority. The 1906 human drug law authorized the Secretaries of Treasury, Agriculture, and Commerce and Labor to promulgate regulations. The 1913 animal virus and toxin law authorized the Secretary of Agriculture to promulgate regulations.
Criminal prosecution. The 1906 human drug law directed inspectors to report violations to the District Attorney for prosecution, with the Secretary of Agriculture certifying the facts, under oath, as found through specimen examination, and charged the DAs to prosecute. The 1913 animal virus and toxin law was silent on procedures for criminal prosecution of violations.
Testing imports. The 1906 human drug law authorized the Treasury Secretary to collect and submit samples of imported human drugs for analysis to determine adulteration or misbranding. The 1913 animal virus and toxin law was silent on Secretary of Agriculture authority to collect samples of imported products for analysis to determine if they are worthless or harmful.
**In 1915, Congress funded a special study of pellagra.
**In 1916, Congress funded "studies of rural sanitation" and added, for the first time, a $10,000 line item for "Biologic products: to regulate the propagation and sale of viruses, serums, toxins and analogous products."
**In 1917, Congress funded "biologic products" regulation with $20,000 and added "infantile paralysis" to the list of diseases eligible for federal payments to state and local health boards under the Prevention of Epidemics program.
**In 1918, Congress provided $30,000 for the PHS biologic products regulation program.
**1919 - Congressional funding act authorized PHS to "prepare" curative and diagnostic biological products
In 1919, Congress funded a new PHS Division of Venereal Diseases (authorized by Act approved July 9, 1918) and provided $20,000 for purchase of equipment and furniture for new Hygienic Lab buildings.
In 1919, Congress added influenza to the list of diseases eligible for federal payments to state and local health boards under the Prevention of Epidemics program, and added to the "biologic products" regulation line item ($35,000 that year), the phrase: "and for the preparation of curative and diagnostic biologic products."
Key points:
From 1919 to the present, the Public Health Service has been Congressionally-authorized to "prepare" viruses, toxins and related biological products within federal facilities, referring to the products as being "curative" and "diagnostic."
These PHS products are prepared under the 1902 Virus-Toxin law and its successor statutes and regulations, which have never established physical or chemical standards for product identity, purity or other measurable attributes; have never defined adulteration or misbranding or set measurable standards for safety and efficacy; have never prohibited preparation and use of adulterated, misbranded, toxic products; have never established or enforced specimen collection and testing procedures; and have never established or enforced product recall, seizure, analysis, destruction or prosecutorial procedures.
**In 1920, Congress authorized PHS officers to be credited with service in the Army, Navy, Marine Corps and Coast Guard in computing longevity pay, and prohibited PHS from using money for "advertising in newspapers, magazines or periodicals for any purpose other than the procurement of bids."
**In 1921, Congress added “arsphenamine” to the list of biologic products. By 1921, the annual biologic product appropriation for regulation of licensed establishments and preparation of products by PHS Hygienic Lab employees was $50,000.
1921 - Sheppard-Towner "act for the promotion of the welfare and hygiene of maternity and infancy." PL 67-97
In 1921, Congress passed "An Act for the promotion of the welfare and hygiene of maternity and infancy." It was a precursor to Title V of the Social Security Act of 1935 (Grants to states for maternal and child welfare), and conditioned federal grants to State governments, on State government participation in federal programs.
Due for renewal in 1926, the Act faced opposition from several different organizations, was extended for two years, and expired in June 1929.
Summary:
Section 1 - Congress authorized annual appropriations to be given to the States, "for the purpose of cooperating with them in promoting the welfare and hygiene of maternity and infancy."
Section 2 - Congress authorized $480,000, followed by $240,000 per year for five years, to be "equally apportioned," plus $1 million per year for five years, apportioned at $5,000 per state, with the balance "in the proportion which their population bears to the total population" and conditioned the population-based money on the State legislatures appropriating equal sums.
Section 3 - Congress created a Board of Maternity and Infant Hygiene, comprised of the Chief of the Children's Bureau of the Department of Labor, Surgeon General of the Public Health Service, and Commissioner of Education, and assigned administration of the Maternity and Infant Hygiene programs to the Chief of the Children's Bureau, whose duties included "to make or cause to be made such studies, investigations and reports and will promote the efficient administration of this Act."
Section 4 - Congress required participating States to have their legislatures accept the federal act provisions, and designate or authorize creation of State agencies with which the federal Children's Bureau could cooperate. Congress further authorized governors of States whose legislatures didn't pass state laws to accept (by executive act) the federal provisions and designate or create corresponding State agencies, while "awaiting legislative action."
Section 5 - Congress authorized up to 5 percent of annual additional appropriations to be spent by the Children's Bureau for administrative expenses.
Section 6 - Congress authorized the Children's Bureau to employ assistants, clerks and other staff from the Civil Service Commission, and to purchase supplies, equipment, and incur travel expenses.
Section 7 - Congress required the Children's Bureau to apportion the additional money -- by population -- within 60 days after each Congressional funding act, to report estimates to the Treasury Secretary and to certify the apportioned amounts to the Treasury Secretary and the State treasurers.
Section 8 - Congress required States "desiring to receive the benefits" to submit detailed compliance plans to the Children's Bureau, with a provision that State plans should forbid State officers "entering homes, etc." to remove children "over the objection of the parents."
Section 9 - Congress forbade Children's Bureau officers from entering any home "over the objection of the owner thereof, or to take charge of any child over the objection of the parents," and added "Nothing in this Act shall be construed as limiting the power of a parent or guardian...to determine what treatment or correction shall be provided for a child or the agency or agencies to be employed for such purpose."
Section 10 - Congress charged the Children's Bureau to monitor the State appropriations and certify to the Treasury Secretary the State contributions and the federal money apportioned to each State. The certificate was to record that the State legislature and/or governor had accepted the provisions of the federal Act; that the State agency had submitted plans for carrying out the federal Act's provisions; the amount appropriated by the State legislature; and the amount of federal money to which the population of the recipient State was entitled. The Children's Bureau certificate would trigger the disbursement, by the Treasury Secretary, of the federal payments to the States.
Section 11 - Congress required State agencies to provide reports to the Children's Bureau about their operations and expenditures and authorized the Children's Bureau board to withhold the certificates (described in Section 10) from any State whose agency "has not properly expended the money paid to it," provided that the Children's Bureau gave notice to the State agency stating the State's specific compliance failures.
Section 12 - Congress prohibited use of the money for purchasing, building or repairing buildings or equipment, or for purchase or rental of buildings or lands, and prohibited use of the State-appropriated money for "the payment of any maternity or infancy pension, stipend or gratuity."
Section 13 - Congress required the Children's Bureau to perform the duties under the supervision of the Secretary of Labor, and required the Labor Secretary to provide annual reports to Congress.
Section 14 - Congress stated that the Act should be "construed as intending to secure to the various States control of the administration of this Act within their respective States, subject only to the provisions and purposes of this Act."
Key points:
The Sheppard-Towner maternity and infant hygiene act of 1921 linked State receipt of federal money to State compliance with federally-directed programs, and to State collection and reporting of detailed population and birth rate information to federal authorities.
The Sheppard-Towner Act was an important step in the undermining of federalist principles: separation of powers between federal and State governments. The Sheppard-Towner Act and the Social Security Act of 1935 both used bribery to entrap families and State governments brought to financial instability through inflation-deflation, boom-bust cycles orchestrated by central bankers through monetary policy decisions, but attributed to natural economic forces.
**In 1922, Congress added Rocky Mountain spotted fever to the list of diseases eligible for federal payments to state and local health boards under the Prevention of Epidemics program
**In 1923, Congress authorized the Immigration Service to permit the PHS to use Ellis Island Immigration Station hospitals for care of PHS patients.
**In 1924, Congress authorized PHS to spend money under the Prevention of Epidemics program for "purchase of newspapers and clippings from newspapers containing information relating to the prevalence of disease and the public health."
**In 1927, Congress authorized a survey of the "salt-marsh areas of the South Atlantic and gulf States, to determine the exact character of the breeding places of the salt-marsh mosquitoes."
**1927 - USDA Bureau of Chemistry name changed to Food, Drug and Insecticide Administration - 44 Stat. 976, at p. 991 and 1002
In 1927, through a funding act, Congress transferred the Department of Agriculture Bureau of Chemistry's regulatory functions — including its duties to collect and examine specimens of manufactured drugs for compliance with the 1906 Pure Food and Drug Act — to a new USDA division called the Food, Drug, and Insecticide organization.
The Bureau of Chemistry's non-regulatory research program was renamed the Bureau of Chemistry and Soils, "for conducting the investigations contemplated by the Act of May 15, 1862 [Act to establish Department of Agriculture], relating to the application of chemistry to agriculture; for the biological investigation of food and drug products and substances used in the manufacture thereof, including investigations of the physiological effects of such products on the human organism; [and] to cooperate with associations and scientific societies in the development of methods of analysis."
Congress directed the new Food, Drug and Insecticide Administration "to cooperate with associations and scientific societies in the revision of the United States Pharmacopoeia and development of methods of analysis..." and established:
“Hereafter the examinations of specimens of foods, drugs, insecticides, Paris greens, lead arsenates, and fungicides provided for by section 4 of the Food and Drugs Act of June 30, 1906, and by section 4 of the Insecticide Act of 1910, shall be made in the Food, Drug, and Insecticide Administration or in such other branches of the Department of Agriculture as the Secretary of Agriculture may direct.”
In 1930, through another funding act, Congress shortened the name of the division to the Food and Drug Administration - 46 Stat 392, at p. 422
Key points:
Congress did not authorize the Food, Drug and Insecticide Administration, or the Food and Drug Administration, Bureau of Chemistry and Soils, or any other USDA division, to regulate viruses, toxins, vaccines or other biological products to identify adulterated or misbranded products under the 1902 Virus-Toxin law, which law did not define or prohibit adulteration or misbranding of viruses and toxins.
Congress also did not charge the USDA divisions with collecting, testing, analyzing or providing sworn testimony as to the physical or chemical properties of viruses, toxins, vaccines or other biological products.
**In 1928, Congress began authorizing traveling expenses for PHS officers to "attend meetings of associations for the promotion of public health" and for the transportation of personal effects for PHS officers, pharmacists and nurses "upon permanent change of station."
**In 1929, the list of diseases identified in Congressional funding acts as authorizing Presidents (in their discretion) to fund state and local health boards, included "threatened or actual epidemic of cholera, typhus fever, yellow fever, typhoid fever, smallpox, bubonic plague, Chinese plague or black death, trachoma, influenza, Rocky Mountain spotted fever, or infantile paralysis."
1929 - Act to establish narcotic farms, precursor to NIH Division of Mental Hygiene - PL 70-672
In 1929, Congress passed an Act "to establish two US narcotic farms for the confinement and treatment of persons addicted to the use of habit-forming narcotic drugs who have been convicted of offenses against the United States, and for other purposes" and placing the institutions under the control of the Treasury Secretary and under the medical supervision of the PHS Surgeon General, through a new Narcotics Division.
Summary:
Section 1 - Congress defined narcotic as "opium and coca leaves and the innumerable alkaloids derived therefrom, the best known...being morphia, heroin and codeine...cocaine...Indian hemp...and peyote..."
Congress defined "addict as "any person who habitually uses any habit-forming narcotic drug...so as to endanger the public morals, health, safety or welfare, or who is...so far addicted...as to have lost the power of self-control with reference to his addiction..."
Section 2 - Congress assigned the Attorney General, Treasury Secretary and Secretary of War to select sites for two institutions" to house convicted addicts and "addicts who voluntarily submit themselves for treatment." (The two facilities were later built in Lexington, Kentucky and Fort Worth, Texas.)...
At Section 5, Congress created a Narcotics Division within the PHS Office of the Surgeon General, to be directed by a physician in charge of the "management, discipline and methods of treatment" of addicts.
At Section 6, Congress authorized the Treasury Secretary to promulgate regulations, and directed the Surgeon General to provide State representatives "the benefit of his experience...through the publication and dissemination of information on methods of treatment and research in this field...to the end that each State" would provide similar facilities within their jurisdictions.
At Section 9, Congress authorized the Treasury Secretary to "establish industries, plants, factories or shops [within the narcotic farms] for the manufacture of articles, commodities and supplies" for the US Government.
At Section 10, Congress prohibited parole until the Surgeon General certified that the inmate is no longer a narcotic addict, and at Section 11, Congress directed Surgeon General examination of all inmates within one month of the expiration of their sentences.
At Sections 15 and 16, Congress prohibited "escape or attempt to escape from a narcotic farm," punishable by up to 5 years imprisonment in addition to the original sentence, and prohibited assisting such escape attempts, punishable by up to three years imprisonment.
In June 1930, Congress changed the name of the PHS Narcotics Division to Division of Mental Hygiene (PL 71-357) and authorized and directed the Surgeon General to "make such studies and investigations...of the abusive use of narcotic drugs; of the quantities of crude opium, coca leaves, and their salts, derivative and preparations....as are necessary to supply the normal and emergency medicinal and scientific requirements of the United States; and of the causes, prevalence, and means for the prevention and treatment of mental and nervous diseases..."
This law is relevant to the history of federal quarantine and biological product law for several reasons. It created a pool of incarcerated subjects for drug research projects; it deepened federal-state financially-incentivized cooperation in alleged public health program operations; and it supported the attribution of mental and neurological disorders to factors other than injection of foreign biological material into humans and other mammals, creating an effective mechanism for suppressing public understanding of the connection between neurological disorders and vaccination.
The model — setting up and funding PHS and NIH divisions and institutes to allegedly look for causes of chronic diseases and thereby direct attention away from their induction by vaccination — has been replicated for many other disorders, including cancer, Sudden Infant Death Syndrome and autism.
**In 1930, the year the Hygienic Laboratory was renamed as the National Institute of Health (see below), Congress funded design and construction of the two narcotic farms and reduced the infectious disease list (diseases authorizing Presidents to supply funds to state and local health boards for prevention of epidemics) from the specific list (cholera, typhus, etc.) to the general form: "threatened or actual epidemic of infectious or contagious disease."
**In 1930 Congress also funded "educational exhibits...the preparation of public-health exhibits designed to demonstrate the cause, prevalence, methods of spread, and measures for preventing disease dangerous to the public health..." including "acquiring, transporting, and displaying exhibit material."
1930 - An Act to provide for coordination of public-health activities of the Government - PL 71-106
In April 1930, Congress passed "An Act to provide for the coordination of the public-health activities of the Government, and for other purposes."
Through this law, Congress gave the Treasury Secretary power to establish new divisions within the Public Health Service, and expanded, named (as the National Advisory Health Council) and added to the duties of the Hygienic Lab advisory board, a second function: to "advise" the PHS Surgeon-General "in respect to public-health activities."
Congress did not define public health and Congress did not assign the staff of the Hygienic Laboratory or the National Advisory Health Council any specific duties to draft or enforce regulations governing the propagation of viruses, toxins, vaccines and other biological products.
Summary:
Section 1 - Congress authorized the Treasury Secretary to detail PHS officers to any federal executive department or "independent establishment which is carrying on a public-health activity...to cooperate in such work," and to pay PHS officers for such work.
Section 2 - Congress authorized the PHS Surgeon General to detail PHS employees to "educational and research institutions" to study and disseminate information on "scientific problems relating to public health;" and to make federal PHS facilities available to health officials and scientists. Congress authorized the Treasury Secretary to establish additional divisions in the Hygienic Lab in Washington DC, "as he deems necessary," and set up facilities to coordinate research and "demonstrations of sanitary methods and appliances."
Section 3 - Congress set up the structure of the Public Health Service to include administrative offices, and "field service" offices, the latter including "scientific offices and research laboratories."
Sections 4 and 5 - Congress authorized the President to set up regulations for the appointment of medical, dental, sanitary engineer and pharmacist officers.
Section 6 - Congress authorized the Treasury Secretary to order officers in the PHS reserve corps to active duty for training and assessment of "fitness" for the regular corps.
Section 7 - Congress authorized the President, upon notice by the Treasury Secretary, to appoint non-commissioned officers to positions requiring "highly specialized training and experience in scientific research" when commissioned officers were not available.
Sections 8 and 9 - Congress addressed pay for officers older than 45 disabled in the line of duty, examinations, promotions, length of service, pay and allowances.
Section 10 - Congress authorized the President to prescribe titles for commissioned officers, designated Assistant Surgeon Generals as "medical directors;" removed the prior limit on the number of active-duty senior surgeons and Assistant Surgeons General at large; and increased the pay of the PHS Surgeon General to match the Army Surgeon General.
Section 11 - Congress authorized the Treasury Secretary to appoint all officers and employees of the PHS other than commissioned officers, with a provision barring the Treasury Secretary from setting up qualification rules giving preference to candidates from any specific school of medicine.
Section 12 - Congress authorized PHS officers disabled "on account of sickness or injury incurred in line of duty" to receive medical, surgical and hospital services.
Section 13 - Congress named the 9-member advisory board to the Hygienic Laboratory (established in 1902 "for consultation relative to the investigations to be inaugurated, and the methods of conducting the same") the National Advisory Health Council; expanded its size to 14 members; authorized the PHS Surgeon General and Treasury Secretary to appoint the five additional board members, "from representatives of the public-health profession;" and tasked the board to "advise" the PHS Surgeon-General "in respect to public-health activities."
Key points:
Through this law, Congress gave the Treasury Secretary power to establish new divisions within the Public Health Service, and expanded, named and added to the duties of the Hygienic Lab advisory board.
Congress did not define the term public health.
Congress did not assign the National Advisory Health Council any specific duties to draft or enforce regulations governing the propagation of viruses, toxins and other biological products.
In 1944, through the Public Health Service Act of 1944, Congress assigned duties to the NAHC to provide "recommendation," along with the PHS Surgeon General, to the President for specifying (by Executive Order) communicable diseases, the prevention of which would authorize "apprehension, detention or conditional release of individuals" under quarantine regulations.
In 2002, Congress eliminated the "prerequisite for National Advisory Health Council recommendation before issuing quarantine rules" and downgraded the PHS Surgeon General's role from "recommendation" provider to the President, to provider of "consultation" to the HHS Secretary, who had taken over the Surgeon General's functions through another series of amendments, reorganizations, and authority transfers.
1930 - Hygienic Laboratory name changed to National Institute of Health; private research funding system established - PL 71-251
One month later, in May 1930, Congress changed the name of the Hygienic Laboratory to the National Institute of Health and created in it a system of fellowships and donation authorizations for “ascertaining the cause, prevention and cure of disease affecting human beings.”
Summary:
Section 1 - Congress changed the name of the Hygienic Laboratory of the Public Health Service to the National Institute of Health, and transferred all "laws, authorizations and appropriations" to the new institute. Congress authorized the Secretary of the Treasury to use the existing Hygienic Lab site in Washington DC and to acquire more sites. Congress directed the Surgeon General to select, as administrators and employees, "persons who show unusual aptitude in science," and authorized appropriation of $750,000 for construction and equipment of additional buildings.
Section 2 - Congress authorized the Treasury Secretary to accept "gifts made unconditionally by will or otherwise for study, investigation, and research in the fundamental problems of the diseases of man" and for purchase of land and construction and equipment of buildings, with the proviso that "conditional gifts may be accepted if recommended by the Surgeon General and National Advisory Health Council," to be held in trusts, invested by the Treasury Secretary in US securities, and the principal or income spent for NIH purposes. Donations over $500,000 for research would be "acknowledged permanently" by the establishment of memorials, and the Surgeon General was authorized to establish NIH fellowships from donated funds.
Section 3 - Congress authorized the Surgeon General to appoint individual scientists (other than commissioned PHS officers) to NIH duties, and authorized the Treasury Secretary to promulgate regulations. Congress authorized the Surgeon General to designate fellowship scientists to conduct research in "other localities and institutions in this and other countries" during their fellowships.
Section 4 - Congress authorized the Treasury Secretary, with recommendations from the Surgeon General, under regulations approved by the President, to designate titles and fix compensation; to fix compensation for clerical and other assistants under civil service laws; and to spend funds for personal services, rents, reference books periodicals, exhibits, printing and binding.
Section 5 - Congress directed that NIH facilities be made available to "bona fide health authorities of States, counties, or municipalities for purposes of instruction and investigation."
Section 6 - Congress established that the NIH Director would have the rank, pay and allowance of a PHS medical director.
Key points:
Congress set up a mechanism for unconditional and conditional private financing of federal public health research, and the employment of non-governmental scientists.
Congress further linked the public health functions of State, county and municipal governments to federal scientific and medical research programs.
**In 1931, Congress renamed the Narcotics Division as the Division of Mental Hygiene.
**In 1934, Congress funded, under the Division of Mental Hygiene, Narcotic Farm, Lexington, Kentucky, "expenses incurred in pursuing and identifying escaped inmates and of interment or transporting remains of deceased inmates."
1935 - Federal Register Act - PL 74-251
Through the Federal Register Act, Congress elaborated on the process for executive legislation, further eroding the separation of powers doctrine and transferring legislative authority to the executive branch.
Summary:
Section 1 - Congress charged the US Archivist to create a new division in the National Archives Establishment, to print and distribute documents listed in Section 5, and authorized the President to appoint a director of the Division.
Section 2 - Congress required document sources (President, federal agencies, etc.) to provide an original and two copies of the documents listed in Section 5. The Division Director was required to log the documents by date and hour; make one copy immediately available for public inspection; store the original in the National Archives and send a copy to the Government Printing Office for printing.
Section 3 - Congress directed the Government Printing Office to publish all the documents listed in Section 5 "in a serial publication designated the 'Federal Register,' " to be published and distributed daily, and to contain the documents filed with the Division the previous day.
Section 4 - Congress defined document to mean "Any Presidential proclamation or Executive order and any order, regulation, rule, certificate, code of fair competition, license, notice, or similar instrument issued, prescribed, or promulgated by a Federal agency." Congress defined Federal agency to mean "the President...or any executive department, independent board, establishment, bureau, agency, institution, commission, or separate office of the administrative branch...but not the legislative or judicial branches..."
Section 5 - Congress listed the documents to be published in the Federal Register, including "all Presidential proclamations and Executive orders," with exceptions for those with "no general applicability...or effective only against Federal agencies or persons in their capacity as officers, agents, or employees;" documents the President determined "have general applicability and legal effect;" documents required to be published in the Federal Register by Act of the Congress; and other documents authorized by regulations prescribed with the President's approval, but not "comments or news items of any character."
Section 6 - Congress established a permanent Administrative Committee of three members: the Archivist, a Department of Justice officer appointed by the Attorney General, and the Public Printer. Congress charged the committee with prescribing regulations to carry out the Federal Register Act provisions, including how agencies should submit certified copies of regulations and other documents, which documents should be published, the number of copies, prices to be charged for copies, and other details.
Section 7 - Congress established that no documents published "shall be valid as against any person who has not had actual knowledge thereof" until the originals or certified copies had been filed and made available for public inspection, but availability of public inspection would "be sufficient to give notice...to any person subject thereto." Congress established that publication in the Federal Register created a "rebuttable presumption" that all the filing requirements had been fulfilled, and directed that the contents of the Federal Register "shall be judicially noticed" and cited by volume and page number.
Section 8 - Congress established that publication of notice in the Federal Register — for example, notices of public hearings — would be "deemed" as properly given to all persons residing within the continental United States if published within the Congressionally required time prescribed, or not less than 15 days if no time period prescribed by Congress.
Section 9 - Congress authorized the Treasury Department to take receipt of payments made for copies of the Federal Register, and charged the printing and distribution costs to the appropriations to the Government Printing Office. Congress authorized free use of the US mails for copies mailed by the US Government.
Section 10 - Congress made the provisions of Section 2 effective 60 days after approval (approval was July 26, 1935) and ordered publication to begin three days after that.
Section 11 - Congress required each agency, within six months after approval, to compile all the documents that had been issued before passage of the Federal Register Act and "still in force and effect and relied upon by the agency," and submit the compilations to the committee named in Section 6. Congress required the committee to report on the pre-Federal Register Act regulations and other documents to the President within two months after that, and required the President to determine "which of such documents have general applicability and legal effect" and authorize publication of a special edition of the Federal Register to publish those pre-Federal Register Act documents.
Section 12 - Congress exempted "treaties, conventions, protocols, and other international agreements, or proclamations thereof by the President."
Section 13 - Congress repealed all other acts to the extent they were in conflict with the Federal Register Act.
Key points.
Congress formally transferred legislative authority to President, Cabinet secretaries and agency officers, by setting up a system for executive branch legislation, further undermining the separation of powers between legislative and executive branch.
1935 Social Security Act - PL 74-271
Congress passed the Social Security Act in August 1935, under the full title: "An Act to provide for the general welfare by establishing a system of Federal old-age benefits, and by enabling the several States to make adequate provision for aged persons, blind persons, dependent and crippled children, maternal and child welfare, public health, and the administration of their unemployment compensation laws; to establish a Social Security Board; to raise revenue; and for other purposes."
When first enacted, the Social Security Act had 11 titles, or sections, including: Title I, Grants to States for Old-Age Assistance; Title II, Federal Old-Age Benefits; Title III, Grants to States for Unemployment Compensation Administration; Title IV, Grants to States for Aid to Dependent Children; Title V, Grants to States for Maternal and Child Welfare, including Maternal and Child Health Services (Part 1), Services for Crippled Children (Part 2), Child-Welfare Services (Part 3), Vocational Rehabilitation (Part 4); Title VI, Public Health Work; Title VII, Social Security Board; Title VIII, Taxes With Respect to Employment; Title IX, Tax on Employers of Eight or More; Title X, Grants to States for Aid to the Blind; and Title XI, General Provisions.
There are now 21 titles, codified at 42 USC Chapter 7, Subchapters I through XXI.
Summarizing only Title VI, Public Health Work, of the original 1935 Social Security Act:
Section 601 - Congress authorized $8,000,000 "for the purpose of assisting States, counties, health districts, and other political subdivisions...in establishing and maintaining adequate public-health services, including...training of personnel..." starting with the fiscal year ending June 30, 1936.
Section 602 - Congress authorized the PHS Surgeon General, with Treasury Secretary approval, to allot the money to the States on the basis of three factors: population, "special health problems" and financial needs. Congress conditioned payments on State health authorities presenting plans to the Surgeon General, and obtaining Surgeon General approval for such plans.
Section 603 - Congress authorized $2,000,000 for the PHS to spend "for investigation of disease and problems of sanitation," including printing and binding of research findings, and travel expenses for PHS employees to travel to States, upon State request, to carry out investigations. Congress required the Treasury Secretary to provide reports to Congress on public health projects annually.
Key Points:
As noted above, the 1921 Sheppard-Towner Act for maternity and child welfare programs undermined federalist principles separating powers between the Federal and State governments, by offering states Federal money — "Grants to States" — on condition that the States adopt and implement Federal policies.
The Sheppard-Towner Act also undermined family, community and religious support networks to transfer the dependency of distressed families from extended family, friends, neighbors and local civic and religious organizations, to State and Federal officers distributing subsidies funded by payroll taxes on employers and employees.
The Sheppard-Towner Act expired in 1929, but most of its provisions were incorporated into the 1935 Social Security Act at Title V.
By linking federal payouts to population data, public health officers created incentives for State use of centralized registries and classification systems for disease diagnosis and cause of death determinations.
1936 - Act to extend PHS services to more seamen - PL 74-483
In 1936, Congress extended Public Health Service "medical relief" to seamen "not enlisted or commissioned in the Military or Naval Establishments" but "employed on US Government vessels (other than those of the Panama Canal) of more than five tons' burden and on State school ships," and to State school ships' cadets.
1937 - During NIH reorganization, Division of Pathology and Bacteriology renamed Division of Biologics Control - NIH accounts of NIH history.
As reported above, in a January 1910 JAMA paper, PHS Hygienic Laboratory Director Milton J. Rosenau referred to the 'division of pathology and bacteriology' as the division responsible for inspecting establishments manufacturing viruses, toxins, serums and analogous products under the 1902 Virus-Toxin law and the 1902 "Act to increase the efficiency and change the name of the...Marine-Hospital Service."
Rosenau's claim is not supported by the text of the 1902 laws, which identified three divisions within the Hygienic Laboratory (chemistry, zoology and pharmacology); vested inspection authority with the Secretary of the Treasury, and vested rule-making authority with a three-member Surgeon-Generals board subject to Treasury Secretary approval.
In 1930, Congress renamed the PHS Hygienic Laboratory as the PHS National Institute of Health and authorized the Treasury Secretary to reorganize and establish new divisions in the Public Health Service.
The Division of Pathology and Bacteriology was renamed the Division of Biologics Control in 1937, during "a reorganization of NIH into eight divisions," according to NIH accounts of NIH history:
"The Division of Biologics Control was established in 1937 at NIH from the laboratory that had responsibility for biologics.
In 1944, the division became the Laboratory of Biologics Control.
And in 1955, the Division of Biologics Standards (DBS) was formed as an independent entity at the NIH, but as the continuation of the previous division and laboratories."
Ostensible responsibility for regulation of viruses, toxins, serums and analogous products remained with the Division of Biologics Standards from 1955 until the DBS was administratively transferred to the Food and Drug Administration in 1972 and renamed the Bureau of Biologics.
**In 1936, Congress changed the name of the Narcotic Farm to The United States Public Health Service Hospital, Lexington, Kentucky; added a program called Grants to States for public-health work, for "assisting States, counties, health districts and other political subdivisions of the States in establishing and maintaining adequate public-health services, including the training of personnel," under provisions of the Social Security Act; and continued funding Diseases and sanitation investigations.
**In 1937, Congress funded a Public Health Service study of "investigations to determine the possibly harmful effects on human beings of spray insecticides on fruits and vegetables," under the Diseases and sanitation investigations program.
1937 - National Cancer Institute Act - PL 75-244
In August 1937, Congress passed the National Cancer Institute Act. The summary is included here because it relates to government and private institution interest in, and knowledge of, the cancer-causing effects of injecting foreign cells and cell-products (toxins) into humans and other mammals, also known as vaccination.
Congress did not define the term cancer in the 1937 law. Since 2009, FDA has defined cancer as "a constellation of more than 100 different diseases, each characterized by the uncontrolled growth and spread of abnormal cells," citing American Cancer Society, 2004. (See January 2009 FDA Guidance for Industry - Evidence-Based Review System for the Scientific Evaluation of Health Claims at p. 8)
Summary of National Cancer Institute Act:
Section 1 - Congress established a PHS division called the National Cancer Institute, to "conduct researches, investigations, experiments, and studies relating to the cause, diagnosis and treatment of cancer," and to help other public and private organizations.
Section 2 - Congress authorized and directed the PHS Surgeon General to carry out the research programs, to promote coordination of research projects conducted by other "agencies, organizations and individuals, to "procure, use and lend radium;" to provide training; to provide fellowships; to obtain advice from cancer researchers in the US and abroad, and to cooperate with State health agencies "in the prevention, control, and eradication of cancer."
Section 3 - Congress created the National Advisory Cancer Council to have six members appointed by the Surgeon General, with Treasury Secretary approval, "from leading medical or scientific authorities who are outstanding in the study, diagnosis, or treatment of cancer," to serve three-year terms.
Section 4 - Congress authorized the National Advisory Cancer Council to review research projects and approve projects that "show promise;" to collect information about studies being carried out in the US or any other country, and publish such information; to review applications from public and private universities, hospitals and laboratories requesting grants for cancer research; to recommend "conditional gifts" for approval by Secretary of the Treasury; and to make recommendations to Surgeon General for carrying out the National Cancer Institute Act.
Section 5 - Congress authorized the Surgeon General to purchase radium; make it available for research projects; and to lend it to institutions studying "the cause, prevention, or methods of diagnosis or treatment of cancer;" to provide training facilities for diagnosis and treatment of cancer; to establish and maintain research fellowships "to procure the assistance of the most brilliant and promising research fellows;" to secure help and advice from experts from the US and abroad; to make grants for research projects; and to adopt additional means to carry out the research projects.
Section 6 - Congress authorized the Treasury Secretary to accept unconditional gifts for research and acquisition of land and construction and maintenance of buildings, and to accept conditional gifts if recommended by the Surgeon General and National Advisory Cancer Council. Congress directed the gifts to be held in trusts and invested in securities of the US, with principal or income expended for cancer research. Congress authorized donations of $500,000 or more to be acknowledged with permanent memorials.
Section 7 - Congress authorized $750,000 for construction and equipment of a building for cancer research and $700,000 per year to support research, traveling expenses, medical books, passenger-vehicles, and printing and binding of publications.
Section 8 - Congress authorized the appointment of commissioned PHS officers to carry out the research programs, and authorized the Surgeon General, with Treasury Secretary approval, to "make such rules and regulations as may be necessary."
Provisions of the 1937 National Cancer Institute Act were incorporated into the Public Health Service Act of 1944 and subsequently expanded.
1938 - Federal Food Drug and Cosmetics Act - PL 75-717
In 1938, Congress passed the Federal Food, Drug and Cosmetic Act. The new law consolidated and expanded on the 1906 Pure Food and Drug Act, incorporating most provisions of the 1906 law — including its definitions for adulterated and misbranded drugs, labeling provisions, and procedures for specimen collection, testing and criminal prosecution — into Chapter 2, Definitions; Chapter 3, Prohibited acts and penalties; Chapter 4, Food; Chapter 5, Drugs and Devices; Chapter 6, Cosmetics; Chapter 7, General Administrative Provisions; Chapter 8, Imports and Exports.
The 1938 law added a section (FDCA Section 505, codified at 21 USC 355) governing "new drugs" and setting up application and review procedures to be carried out by the Secretary of Agriculture.
At Chapter 8, Miscellaneous, Congress explicitly stated:
"Nothing contained in this Act shall be construed as in any way affecting, modifying, repealing, or superseding the provisions of the virus, serum and toxin Act of July 1, 1902."
Congress cited to a reprint of the 1902 Virus-Toxin law published in the 1934 edition of the US Code as a chapter titled Viruses, Serums, Toxins, Anti-Toxins, Etc.
Key point:
The application, inspection, testing, review and compliance enforcement provisions of the 1938 Federal Food, Drug and Cosmetic Act pertaining to product definition, identification, labeling, purity, adulteration and misbranding were inapplicable to manufacturing, licensing, and interstate and international trafficking of viruses, toxins, vaccines and other biological products.
**In 1938, Congress funded the new National Cancer Institute within the PHS, under the National Cancer Institute Act.
1939 Reorganization Act - PL 76-19,
In early April 1939, Congress passed the Reorganization Act of 1939, ostensibly motivated "by reason of continued national deficits beginning in 1931," [following the stock market crash of October 1929 and subsequent economic depression and New Deal programs] making it "desirable to reduce substantially Government expenditures."
The law, not summarized in detail here but available for reader review (PL 76-19), transferred a form of legislative authority from Congress to the President, by authorizing unilateral "transfer, consolidation, or abolition" of federal executive agencies and functions, "more speedily...than by the enactment of specific legislation."
The second part of the act set up complex Congressional rules to make it politically difficult for Congress to debate or reject any reorganization plan prepared by a President, such that transmitted plans were virtually guaranteed to go into effect.
Congress authorized the President to determine the changes needed "to increase...efficiency;...to group, coordinate and consolidate agencies;...to abolish...agencies as may not be necessary; and...to eliminate overlapping and duplication of effort..." and required the President to transmit plans to Congress before Jan. 21, 1941.
In late April 1939, President Roosevelt transmitted Reorganization Plan No. 1 to Congress, followed by Reorganization Plan No. 2, transmitted to Congress in May 1939.
By Joint Resolution adopted June 7, 1939, (Pub Res. 76-138), Congress accepted the two reorganization plans, which went into effect July 1, 1939 and were published in the Federal Register the same day (4 FR 2727 and 2731).
Through Reorganization Plan No. 1 of 1939 and Executive Order 8248 (4 FR 3864, Sept. 8, 1939), Roosevelt created the Executive Office of the President and the Federal Security Agency (FSA), and transferred the Public Health Service and its divisions and functions, from the Treasury Department to the new executive agency. Other agencies transferred to the new Federal Security Agency included the US Employment Service (from Department of Labor); Office of Education (from the Department of the Interior); National Youth Administration (from the Works Progress Administration), and the Civilian Conservation Corps. The FSA was simultaneously consolidated with the Social Security Administration.
Through additional reorganization acts and reorganization plans, the Federal Security Agency was abolished in 1953 and its functions were transferred to the Department of Health, Education and Welfare (HEW). The functions of the Public Health Service and the PHS Surgeon General were transferred to the HEW Secretary in 1966. In 1979, Congress and President Carter passed an act to create the Department of Education, and changed the name of the HEW Department to the Department of Health and Human Services.
Key Points:
The Reorganization Act represents one example of acts through which Congress abdicated its lawmaking authority and its oversight (checks and balances) duties, gutting the separation of powers between the legislative and executive branches.
It's one of the key acts through which Congress created the so-called "Deep State" of permanent civil administrators.
1940-1943 - Biological Warfare Laboratories set up within Federal Security Agency
Although not covered in detail here, readers may be interested in learning more about the establishment, between 1940-1943, within the Federal Security Agency established in 1939 (later renamed Health, Education and Welfare Department, now Health and Human Services Department) of the National Defense Research Committee, Office of Scientific Research and Development, War Bureau of Consultants, War Research Service (biological warfare), and US Army Biological Warfare Laboratories (Camp Detrick), and how the federal government officers and agencies involved in those war programs were related to federal vaccination programs as developed from the late 1940s through the present.
1940 - FDA transferred from Department of Agriculture to Federal Security Agency. (54 Stat. 1234 at 1237)
Under Roosevelt's Reorganization Plan No. 4 of 1940, promulgated under the 1939 Reorganization Act passed by Congress, President Roosevelt transferred the Food and Drug Administration and all of its functions, except its functions under the Insecticide Act of 1910 and the Naval Stores Act, to the Federal Security Agency, under the direction and supervision of the Federal Security Administrator, and renamed the Chief of the Food and Drug Administration as the Commissioner of Food and Drugs.
Key Points:
Reorganization Plan No. 4 was silent as to whether any laboratory would take on the functions formerly carried out by the USDA Bureau of Chemistry, including collection and testing of drug specimens, which again, did not include collection and testing of virus and toxin specimens, which were not subject to regulation under the 1938 Food Drug and Cosmetics Act or the 1906 Pure Food and Drug Act.
** In 1941, Congress funded a new PHS program called Emergency health and sanitation activities (national defense), "to assist State and local health authorities in health and sanitation activities (1) in areas adjoining military and naval reservations, (2) in areas where there are concentrations of military and naval forces, (3), in areas adjoining Government and private industrial plants engaged in defense work and (4) in private industrial plants engaged in defense work..." and another one called Training for nurses (national defense).
**In 1943, Congress funded a new States Relations Division within the PHS, under the Social Security Act of 1935, consolidating federally-funded state-level programs including Grants to States for public-health work (established 1936); Interstate quarantine service (1890, 1913) and Prevention of epidemics (1904).
1943 - Public Health Service Act of 1943 (PL 78-184)
On Nov. 11, 1943, Congress and President Roosevelt passed an act "relating to the organization and functions of the Public Health Service, and for other purposes."
The November 1943 law (which was followed by the July 1944 adoption of the Public Health Service Act of 1944, to be covered in Part 5 of this series) laid out the new organizational structure, "powers and duties," and programs.
Summary of Public Health Service Act of 1943:
Section 1 - Public Health Service in the Federal Security Agency will include Office of the Surgeon General, National Institute of Health (the Hygienic Laboratory established in 1887), and two bureaus: The Bureau of Medical Services and Bureau of State Services.
Congress authorized the PHS Surgeon General, under the supervision and direction of the Federal Security Administrator, to assign all the previously authorized functions of the PHS to the four offices and to establish new "divisions, sections and other units," to "abolish existing divisions, sections and other units," and, from that point on, to "establish, transfer and consolidate divisions, sections, and other units, and reassign their functions for the efficiency of the Service."
Section 2 - Congress directed that the NIH Director would detail, from the regular corps, the "chiefs" of the two new bureaus (medical services and state services) and the Chief Medical Officer of the US Coast Guard, and that while serving in those positions, they would be classified as Assistant Surgeon General with corresponding pay and allowances.
Section 3 - Congress laid out terms for temporary details for officers to serve as division chiefs, and authorized — in the Office of Surgeon General — a Dental Division and a Sanitary Engineering Division.
Section 4 - Congress authorized — "in time of war or national emergency determined by the President" — temporary promotions with increased pay and allowances, and exempted promoted officers from having to renew their oath of office or take a new oath.
Section 5 - Congress set up a system for review of the records of commissioned officers above the level of Assistant Surgeon every three years, and for separation from the Public Health Service for officers found to be unqualified.
Section 6 - Congress set up a continuity plan "in case of the absence or disability of the Surgeon General and the Assistant to the Surgeon General."
Section 7 - Congress amended Sec. 9 of the April 9, 1930 reorganization act to add a paragraph authorizing appointments to a junior grade corresponding to second lieutenant in the Medical Department of the Army, eligible for promotion to Assistant Surgeon grade after one to two years and an examination.
Section 8 - Congress defined the terms "full military benefits," and "limited military benefits," and authorized commissioned officers of the Public Health Service, regular and reserve, to receive full or limited benefits, depending on whether they served "in time of war," while detailed to the Army, Navy or Coast Guard and other factors. Congress further authorized the President, "in time of war...by Executive order" to declare the commissioned corps of the PHS "a part of the military forces of the United States"
Section 9 - Congress authorized PHS commissioned officers to receive benefits for injury or death as civil officers and employees of the United States.
Section 10 - Congress authorized surviving beneficiaries of dead commissioned PHS officers to receive six months' pay and benefits under Sec. 9.
Section 11 - Congress authorized the Federal Security Administrator to transfer funds between appropriations to carry out PHS reorganization, with the approval of the Director of the Bureau of the Budget.
Key points:
Congress transferred all authority to reorganize the Public Health Service to the Surgeon General and Federal Security Administrator, including establishing, transferring and abolishing divisions, and "reassigning functions."
Congress reinforced the status of the Public Health Service as a federal military program.
Congress reinforced that one core function of the federal Public Health Service was "State Services."
BRIEF ANALYSIS:
For this report, the authors are not offering analysis of the parallel developments in speed of telecommunications (enabling disease-outbreak allegations to reach ports before ships); centralization of general and scientific publishing, data collection and statistical disease and cause-of-death classification systems; scientific research into methods of inducing cancer, autoimmune disease, neurological disorders, gastrointestinal disorders and other chronic, life-limiting conditions; transfer of lawmaking authority from legislative to executive branches, weakening of judicial authority by legislative enactment, and federal preemption and bribery to weaken state and local authority.
We plan to publish additional analysis after the series is published in full.
We'd like to focus reader attention on careful review of the Congressional authorization acts and Presidential reorganization acts demonstrating the consistent non-presence of provisions directing federal agencies to establish biological product definitions; to establish measurable, enforceable standards for product identification; labeling; purity; potency; safety; efficacy; or to establish procedures for specimen collection, analysis, recall, seizure, and destruction.
As a result of this non-presence, no federal agency has ever published or enforced rules governing biological product identity, labeling, purity, potency, safety, efficacy or specimen collection, analysis, recall, seizure, and destruction procedures.
[Update Oct. 10, 2024 - Following leads from a 2016 paper by Terry S. Coleman: Early Developments in the Regulation of Biologics (Food and Drug Law Journal, Vol 71, No . 4, pp. 544-607), on Oct. 10, 2024, we located six regulatory publications published before the Federal Register Act:
1903.02.21 PHS Treasury Regulations for the Sale of Viruses, Serums, Toxins and Analogous Products
1909.05.11 PHS Treasury Regulations for the Sale of Viruses, Serums, Toxins and Analogous Products
1919.02.12 PHS Treasury Regulations for the Sale of Virues, Serums, Toxins and Analogous Products
1923.08.01 PHS Treasury Regulations for the Sale of Viruses, Serums, Toxins and Analogous Products
1934.03.13 PHS Treasury Regulations for the Sale of Viruses, Serums, Toxins and Analogous Products
1935.02.25 PHS Treasury Regulations for the Sale of Viruses, Serums, Toxins and Analogous Products]
The earliest version of regulations pertaining to biological products for human use, published in the Federal Register, under executive branch authority as transferred by Congressional statutes, addressing manufacture of viruses, toxins, serums and analogous products, that the authors had located as of October 9, 2024 is a 1940 version, published in the Federal Register on Oct. 17, 1940 (5 FR 4107) and codified at 42 CFR 22.1 to 22.115, Viruses, Serums, Toxins, and Analogous Products.
Careful review of the 1940 human-use biological product regulations codified at 42 CFR 22, and all successor regulations, including:
42 CFR 73, Biologic products, (1947);
21 CFR 273, Biological products, (1972-1973);
42 CFR 73, Select agents and toxins (2002 to present)
demonstrates the consistent non-presence of mandatory provisions (mandatory meaning provisions that are not discretionary, waived, exempted, preempted, suspended, or otherwise rendered inapplicable to biological products including all vaccines) that are essential for the regulation of any product intended for consumption by or injection into human beings:
product definitions enabling product identification by physical or chemical attributes;
physical or chemical product identification standards and identification testing protocols;
safety standards apart from short-term survival tests for animals including rabbits, mice, guinea pigs.
any safety standards for human product recipients;
any efficacy standards for human product recipients;
specimen collection and testing procedures;
assignment of specimen collection and testing duties;
product recall, seizure, analysis, and destruction procedures;
assignment of recall, seizure, analysis and destruction duties;
criminal prosecution procedures;
assignment of criminal prosecution duties.
In other words, virus and toxin manufacturers and regulators have not done the biological product regulatory standard-setting, regulatory compliance and regulatory compliance enforcement that no law has ever required them to do.
Manufacturers have pretended to comply with standards that do not exist, and regulators have pretended to enforce compliance with standards that do not exist.
Why have they jointly engaged in such massive, coordinated, legalized deceit?
To jointly conduct legalized, deniable, interstate and international traffic in heterogeneous, unstable mixtures of poisons — vaccines — for the purpose of intentionally sickening, mutilating and killing people.
Part 5 will cover the interval from the Public Health Service Act of 1944 through 1972 transfer of biological product non-regulation from NIH to FDA.
Lydia Hazel holds degrees in Latin (BA) and linguistics (MA), with minors and concentrations in mathematics, phonetics/phonology, and philology. Her professional background is teaching English as a Second Language. She raised four children, unvaccinated since 1993, after Hazel investigated vaccines when Hepatitis B vaccines were added to the CDC-recommended childhood immunization schedule. She lives in Illinois and is the author of the Medical Countermeasures Awareness Act posted at Bailiwick in February 2024. Email: lydiahazel@aol.com.